COBRA PZF™ Coronary Stent for Early Healing, Thrombus Inhibition, Endothelialization and Avoiding Long-Term DAPT

Coronary Artery Disease Clinical Trial

Official title:

COBRA PZF™ Coronary Stent System in Native Coronary Arteries for Early Healing, Thrombus Inhibition, Endothelialization and Avoiding Long-Term Dual Anti-Platelet Therapy. The PzF Shield Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01925794
• Other study ID #: COBRA 2012-01
• Status: Completed
• Phase: N/A
• Start date: August 21, 2013
• Est. completion date: March 2, 2020

Study information

• Verified date: March 2021
• Source: CeloNova BioSciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, multi-center, non-randomized, single arm clinical trial that will be conducted at up to 40 sites in the United States and Outside United States (OUS). This study will enroll patients with symptomatic ischemic heart disease due to a single de novo lesion contained within a native coronary artery with reference vessel diameter between 2.5 mm and 4.0 mm and lesion length ≤ 24 mm that is amenable to percutaneous coronary intervention (PCI) and stent deployment. All patients will be followed at 30 days, 6 months, 9 months, 1 year and annually for 5 years post index stenting procedure.

Description:

The main objective of this study is to evaluate the safety and effectiveness of the COBRA PzF™ Coronary Stent System in the treatment of de novo lesions in native coronary arteries. The primary endpoint will be the incidence of target vessel failure (TVF, see definition below) within 270 days of treatment with the COBRA PzFTM Coronary Stent System. This rate will be compared to a performance goal derived using a meta-analysis from published historical data of the standard-of-care therapy, coronary stenting with bare metal stents.

PRIMARY STUDY HYPOTHESIS The CeloNova COBRA PzFTM Study will have a primary endpoint (TVF) rate less than 19.62% and by that will meet the performance goal for bare metal stents, per the results of the historical control group combined with relevant data for EXPRESS™, Driver™, Presillion/Presillion plus™ and NIRFLEX™ stents.

SECONDARY STUDY HYPOTHESIS The powered secondary endpoint for this trial is that the CeloNova COBRA PzFTM Study will have a 9-month in-stent late loss (LL) that meets or is lower than the performance goal of 1.1 mm.

NUMBER OF PATIENTS 296 patients will be enrolled to account for loss to follow-up, which is estimated to be approximately 5% (resulting in 281 evaluable patients), at up to 40 sites in United States and OUS. At least 40% of subjects will be enrolled in the United States.

PRIMARY ENDPOINT Target vessel failure (TVF), defined as cardiac death, target vessel myocardial infarction (MI) [Q wave or non-Q wave, ARC-definition], or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods within 270 days post-procedure.

SECONDARY ENDPOINTS

1. All Death at 30, 180, 270, 360, 720, 1080, 1440, and 1800 days

2. Cardiac Death at 30, 180, 270, 360, 720, 1080, 1440, and 1800 days

3. Major Adverse Cardiac Events (MACE), defined as cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods at 30, 180, 270, 360, 720, 1080, 1440, and 1800 days

4. MI at 30, 180 and 270, 360, 720, 1080, 1440, and 1800 days CeloNova Biosciences, Inc. Confidential CeloNova COBRA PzF™ Study Protocol # COBRA 2012-01 6 07 May 14

5. Clinically driven TLR at 30, 180, 270, 360, 720, 1080, 1440, and 1800 days

6. Stroke (ischemic and hemorrhagic) at 30, 180, 270 and 360 days

7. Clinically driven TVR at 30, 180, 270 and 360 days

8. Composite Endpoint of Cardiac Death and MI at 30, 180, 270, and 360 days

9. TVF at 30, 180, and 360 days

10. Acute Success Rates

1. Device Success: Attainment of < 30% final residual stenosis of the target lesion using only the COBRA PzFTM Coronary Stent System.

2. Lesion Success: Attainment of < 30% final residual stenosis of the target lesion using any percutaneous method.

3. Procedure Success: Attainment of < 30% final residual stenosis of the target lesion and no in-hospital MACE.

11. Bleeding or Vascular Complications at hospital discharge

12. Early Stent Thrombosis (ARC defined) at 30 days

13. Late Stent Thrombosis at 180, 270, and 360 days

14. Angiographic Endpoints (on first 90 evaluable patients) at 270 days (after clinical assessment)

1. In-stent late loss (Secondary Endpoint hypothesis)

2. In-segment percent diameter stenosis (%DS) (within the 5 mm margins proximal and distal to stent)

3. In-stent percent diameter stenosis (%DS)

4. In-segment late loss

5. In-segment binary restenosis (stenosis of > 50% of the reference vessel diameter)

6. In-stent binary restenosis

7. In-stent minimum lumen diameter (MLD)

8. In-segment MLD

9. Longitudinal stent deformation

10. Stent fracture

15. Optical Coherence Tomography Endpoints (on 45 subjects) at 270 days (after clinical assessment)

1. in-stent neointimal thickness (NT)

2. Lumen area

3. Lumen volume

4. Stent area

5. Stent volume

6. Proportion of uncovered and/or malopposed struts

7. Stent fracture

Recruitment information / eligibility

• Status: Completed
• Enrollment: 296
• Est. completion date: March 2, 2020
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

General Inclusion Criteria:

1. Patient >/= to 18 years old.

2. Eligible for percutaneous coronary intervention (PCI).

3. Patient understands the nature of the procedure and provides written informed consent prior to the catheterization procedure.

4. Patient is willing to comply with specified follow-up evaluation and can be contacted by telephone.

5. Acceptable candidate for coronary artery bypass graft (CABG) surgery.

6. Stable angina pectoris (Canadian Cardiovascular Society (CCS) 1, 2, 3 or 4) or unstable angina pectoris (Braunwald Class 1-3, B-C) or a positive functional ischemia study (e.g., ETT, SPECT, Stress echocardiography or Cardiac CT).

7. Male or non-pregnant female patient (Note: females of child bearing potential must have a negative pregnancy test prior to enrollment in the study).

Angiographic Inclusion Criteria

1. Patient indicated for elective stenting of a single stenotic lesion in a native coronary artery.

2. Reference vessel >/= 2.5 mm and </= 4.0 mm in diameter by visual estimate.

3. Target lesion </= 24 mm in length by visual estimate (the intention should be to cover the whole lesion with one stent of adequate length).

4. Protected left main lesion with >50% stenosis.

5. Target lesion stenosis >/= 70% and < 100% by visual estimate.

6. Target lesion stenosis <70% who meet physiological criteria for revascularization (i.e. positive FFR).

General Exclusion Criteria:

1. Currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.

2. Previously enrolled in another stent trial within the prior 2 years.

3. ANY planned elective surgery or percutaneous intervention within the subsequent 3 months.

4. A previous coronary interventional procedure of any kind within 30 days prior to the procedure.

5. The patient requires staged procedure of either the target or any non-target vessel within 9 months post-procedure.

6. The target lesion requires treatment with a device other than PTCA prior to stent placement (such as, but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.).

7. Previous drug eluting stent (DES) deployment anywhere in the target vessel.

8. Any previous stent placement within 15 mm (proximal or distal) of the target lesion.

9. Co-morbid condition(s) that could limit the patient's ability to participate in the trial or to comply with follow-up requirements, or impact the scientific integrity of the trial.

10. Concurrent medical condition with a life expectancy of less than 12 months.

11. Documented left ventricular ejection fraction (LVEF) < 30% within 12 months prior to enrollment.

12. Patients with diagnosis of MI within 72 hours (i.e. CK-MB must be returned to normal prior to enrollment) or suspected acute MI at time of enrollment

13. Previous brachytherapy in the target vessel.

14. History of cerebrovascular accident or transient ischemic attack in the last 6 months.

15. Leukopenia (leukocytes < 3.5 x 10(9) / liter).

16. Neutropenia (Absolute Neutrophil Count < 1000/mm3) </= 3 days prior to enrollment.

17. Thrombocytopenia (platelets < 100,000/mm3) pre-procedure.

18. Active peptic ulcer or active GI bleeding.

19. History of bleeding diathesis or coagulopathy or inability to accept blood transfusions.

20. Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, nickel, L-605 Cobalt chromium alloy or sensitivity to contrast media, which cannot be adequately pre-medicated.

21. Serum creatinine level > 2.0 mg/dl within 7 days prior to index procedure.

22. Patients unable to tolerate dual anti-platelets therapy (DAPT) for one month post procedure.

Angiographic Exclusion Criteria

1. Unprotected left main coronary artery disease (obstruction greater than 50% in the left main coronary artery that is not protected by at least one non-obstructed bypass graft to the LAD or Circumflex artery or a branch thereof).

2. Target vessel with any lesions with greater than 50% diameter stenosis outside of a range of 5 mm proximal and distal to the target lesion based on visual estimate or on-line QCA.

3. Target lesion (or vessel) exhibiting an intraluminal thrombus (occupying > 50% of the true lumen diameter) at any time.

4. Lesion location that is aorto-ostial or within 5 mm of the origin of the left anterior descending (LAD) or left circumflex (LCX).

5. Target lesion with side branches > 2.0mm in diameter.

6. Target vessel is excessively tortuous (two bends > 90° to reach the target lesion).

7. Target lesion is severely calcified.

8. TIMI flow 0 or 1

9. Target lesion is in a bypass graft

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• COBRA PzF

Locations

Country	Name	City	State
France	Clinique Axium	Aix en Provence
France	Hopital Henri Duffaut	Avignon
France	Albert Schweitzer Hospital	Colmar
France	Clinique du Diaconat	Mulhouse
France	Centre Hospitalier de Pau	Pau
France	Clinique St. Hilaire	Rouen
Germany	Sankt Kathatinen Hospital	Frankfurt
Germany	Kardiologische Praxis und Praxisklinik	Munchen
Latvia	Paul Stradins Clinical University Hospital	Riga
Serbia	Clinical Center of Serbia	Belgrade
Spain	Hospital de la Santa Creu	Barcelona
Spain	Hospital Clinico San Carlos	Madrid
Switzerland	Kantonsspital St. Gallen	St. Gallen
United States	Emory University Hospital	Atlanta	Georgia
United States	Bakersfield Memorial Hospital	Bakersfield	California
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Deborah Heart & Lung Center	Browns Mills	New Jersey
United States	Cardiology Consultants of Texas	Dallas	Texas
United States	Plaza Medical Center	Fort Worth	Texas
United States	Houston Methodist Hospital	Houston	Texas
United States	Heart Center of Indiana	Indianapolis	Indiana
United States	Louisiana Heart Hospital	Lacombe	Louisiana
United States	St Joseph's Hospital	Liverpool	New York
United States	Texas Cardiac Center	Lubbock	Texas
United States	Southern Oregon Cardiology	Medford	Oregon
United States	Mt Sinai Medical Center	Miami Beach	Florida
United States	Lenox Hill Hospital	New York	New York
United States	Mount Sinai Hospital	New York	New York
United States	Oklahoma Foundation for Cardiovascular Research	Oklahoma City	Oklahoma
United States	The Heart Hospital Baylor Plano	Plano	Texas
United States	Virginia Cardiovascular Specialists	Richmond	Virginia
United States	San Antonio Endovascular & Heart Institute	San Antonio	Texas
United States	Tyler Cardiovascular Consultants	Tyler	Texas
United States	Aspirus Heart & Vascular Institute	Wausau	Wisconsin
United States	York General Hospital	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
CeloNova BioSciences, Inc.

Countries where clinical trial is conducted

United States,  France,  Germany,  Latvia,  Serbia,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target Vessel Failure (TVF)	TVF defined as cardiac death, target vessel myocardial infarction (MI [Q wave or non-Q wave, ARC definition], or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods within 270 days post-procedure.	270 days
Secondary	All Cause Mortality	Death from any cause	30 days
Secondary	All Cause Mortality	Death from any cause	180 days
Secondary	All Cause Mortality	Death from any cause	270 days
Secondary	All Cause Mortality	Death from any cause	360 days
Secondary	All Cause Mortality	Death from any cause	1800 days
Secondary	Cardiac Mortality	Death due to any of the following: Acute myocardial infarction Cardiac perforation/pericardial tamponade Arrhythmia or conduction abnormality Cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure Death due to complication of a cardiac procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery Any death is which a cardiac cause cannot be excluded	30 days
Secondary	Cardiac Mortality	Death due to any of the following: Acute myocardial infarction Cardiac perforation/pericardial tamponade Arrhythmia or conduction abnormality Cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure Death due to complication of a cardiac procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery Any death is which a cardiac cause cannot be excluded	180 days
Secondary	Cardiac Mortality	Death due to any of the following: Acute myocardial infarction Cardiac perforation/pericardial tamponade Arrhythmia or conduction abnormality Cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure Death due to complication of a cardiac procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery Any death is which a cardiac cause cannot be excluded	270 days
Secondary	Cardiac Mortality	Death due to any of the following: Acute myocardial infarction Cardiac perforation/pericardial tamponade Arrhythmia or conduction abnormality Cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure Death due to complication of a cardiac procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery Any death is which a cardiac cause cannot be excluded	360 days
Secondary	Cardiac Mortality	Death due to any of the following: Acute myocardial infarction Cardiac perforation/pericardial tamponade Arrhythmia or conduction abnormality Cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure Death due to complication of a cardiac procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery Any death is which a cardiac cause cannot be excluded	1800 days
Secondary	Major Adverse Cardiac Events (MACE)	Cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods	30 days
Secondary	Major Adverse Cardiac Events (MACE)	Cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods	180 days
Secondary	Major Adverse Cardiac Events (MACE)	Cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods	270 days
Secondary	Major Adverse Cardiac Events (MACE)	Cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods	360 days
Secondary	Major Adverse Cardiac Events (MACE)	Cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods	1800 days
Secondary	Myocardial Infarction (MI-ARC Definition)	Defined as either a Q wave MI (QWMI) or Non-Q wave MI (NQMI). QWMI is defined as development of new, pathological Q waves in 2 or more contiguous leads (as assessed by the Clinical Events Committee) with post-procedure CK-MB levels elevated above normal.; NQWMI is defined as any elevation of post-procedure CK-MB to >=3 times site normal in the absence of pathological Q waves (historical definition). ARC definition includes Troponin or CK-MB >3 x UNL	30 days
Secondary	Myocardial Infarction (MI-ARC Definition)	Defined as either a Q wave MI (QWMI) or Non-Q wave MI (NQMI). QWMI is defined as development of new, pathological Q waves in 2 or more contiguous leads (as assessed by the Clinical Events Committee) with post-procedure CK-MB levels elevated above normal.; NQWMI is defined as any elevation of post-procedure CK-MB to >=3 times site normal in the absence of pathological Q waves	180 days
Secondary	Myocardial Infarction (MI-ARC Definition)	Defined as either a Q wave MI (QWMI) or Non-Q wave MI (NQMI). QWMI is defined as development of new, pathological Q waves in 2 or more contiguous leads (as assessed by the Clinical Events Committee) with post-procedure CK-MB levels elevated above normal.; NQWMI is defined as any elevation of post-procedure CK-MB to >=3 times site normal in the absence of pathological Q waves	270 days
Secondary	Myocardial Infarction (MI-ARC Definition)	Defined as either a Q wave MI (QWMI) or Non-Q wave MI (NQMI). QWMI is defined as development of new, pathological Q waves in 2 or more contiguous leads (as assessed by the Clinical Events Committee) with post-procedure CK-MB levels elevated above normal.; NQWMI is defined as any elevation of post-procedure CK-MB to >=3 times site normal in the absence of pathological Q waves	360 days
Secondary	Myocardial Infarction (MI-ARC Definition)	Defined as either a Q wave MI (QWMI) or Non-Q wave MI (NQMI). QWMI is defined as development of new, pathological Q waves in 2 or more contiguous leads (as assessed by the Clinical Events Committee) with post-procedure CK-MB levels elevated above normal.; NQWMI is defined as any elevation of post-procedure CK-MB to >=3 times site normal in the absence of pathological Q waves	1800 days
Secondary	Cardiac Death or MI (ARC Definition)	Composite Endpoint of Cardiac Death or MI (ARC definition)	30 days
Secondary	Cardiac Death or MI (ARC Definition)	Composite Endpoint of Cardiac Death and MI (ARC definition)	180 days
Secondary	Cardiac Death or MI (ARC Definition)	Composite Endpoint of Cardiac Death or MI (ARC definition)	270 days
Secondary	Cardiac Death or MI (ARC Definition)	Composite Endpoint of Cardiac Death or MI (ARC definition)	360 days
Secondary	Clinically Driven TLR	Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of >= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of >=70% by QCA without either angina or a positive functional study.	30 days
Secondary	Clinically Driven TLR	Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of >= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of >=70% by QCA without either angina or a positive functional study.	180 days
Secondary	Clinically Driven TLR	Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of >= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of >=70% by QCA without either angina or a positive functional study.	270 days
Secondary	Clinically Driven TLR (Clinical and Angiographic Cohorts)	Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of >= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of >=70% by QCA without either angina or a positive functional study.	360 days
Secondary	Clinically Driven TLR (Clinical Cohorts)	Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of >= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of >=70% by QCA without either angina or a positive functional study.	360 days
Secondary	Clinically Driven TLR (Clinical and Angiographic Cohorts)	Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of >= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of >=70% by QCA without either angina or a positive functional study.	1800 days
Secondary	Clinically Driven TLR (Clinical Cohorts)	Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of >= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of >=70% by QCA without either angina or a positive functional study.	1800 days
Secondary	Clinically Driven TVR	Defined as a percutaneous intervention or surgical bypass of any segment of the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >=70% by QCA without either angina or a positive functional study.	30 days
Secondary	Clinically Driven TVR	Defined as a percutaneous intervention or surgical bypass of any segment of the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >=70% by QCA without either angina or a positive functional study.	180 days
Secondary	Clinically Driven TVR	Defined as a percutaneous intervention or surgical bypass of any segment of the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >=70% by QCA without either angina or a positive functional study.	270 days
Secondary	Clinically Driven TVR	Defined as a percutaneous intervention or surgical bypass of any segment of the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >=70% by QCA without either angina or a positive functional study.	360 days
Secondary	Target Vessel Failure (TVF)	TVF defined as cardiac death, target vessel myocardial infarction (MI) [Q wave or non-Q wave, ARC definition], or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods.	30 days
Secondary	Target Vessel Failure (TVF)	TVF defined as cardiac death, target vessel myocardial infarction (MI) [Q wave or non-Q wave, ARC definition], or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods.	180 days
Secondary	Target Vessel Failure (TVF)	TVF defined as cardiac death, target vessel myocardial infarction (MI) [Q wave or non-Q wave, ARC definition], or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods.	360 days
Secondary	Stroke (Ischemic and Hemorrhagic)	Defined as sudden onset of vertigo, numbness, dysphasia, weakness, visual field defects, dysarthria or other focal neurological deficits due to vascular lesions of the brain such as hemorrhage, embolism, thrombosis, or rupturing aneurysm, that persists more than 24 hours.	30 days
Secondary	Stroke (Ischemic and Hemorrhagic)	Defined as sudden onset of vertigo, numbness, dysphasia, weakness, visual field defects, dysarthria or other focal neurological deficits due to vascular lesions of the brain such as hemorrhage, embolism, thrombosis, or rupturing aneurysm, that persists more than 24 hours.	180 days
Secondary	Stroke (Ischemic and Hemorrhagic)	Defined as sudden onset of vertigo, numbness, dysphasia, weakness, visual field defects, dysarthria or other focal neurological deficits due to vascular lesions of the brain such as hemorrhage, embolism, thrombosis, or rupturing aneurysm, that persists more than 24 hours.	270 days
Secondary	Device Success	Attainment of <30% final residual stenosis of the target lesion using only the COBRA PzF Coronary Stent System	30 days
Secondary	Stroke (Ischemic and Hemorrhagic)	Defined as sudden onset of vertigo, numbness, dysphasia, weakness, visual field defects, dysarthria or other focal neurological deficits due to vascular lesions of the brain such as hemorrhage, embolism, thrombosis, or rupturing aneurysm, that persists more than 24 hours.	360 days
Secondary	Lesion Success	Attainment of <30% final residual stenosis of the target lesion using any percutaneous method	30 days
Secondary	Procedure Success	Attainment of <30% final residual stenosis of the target lesion and no in-hospital MACE	30 days
Secondary	Bleeding or Vascular Complications	Bleeding Complications: Procedure-related hemorrhagic event that requires a transfusion and/or surgical intervention Vascular Complications: May include pseudo aneurysm, arteriovenous fistula (AVF), peripheral ischemia/nerve injury, and vascular event requiring transfusion or surgical repair	30 days
Secondary	Early Stent Thrombosis (ARC Definition)	Early Stent Thrombosis (ARC Definition) 0-30 days post index procedure	30 days
Secondary	Late Stent Thrombosis	Stent Thrombosis after 30 days and on or before 180 days	180 days
Secondary	Late Stent Thrombosis	Stent Thrombosis after 30 days and on or before 270 days	270 days
Secondary	Late Stent Thrombosis	Stent Thrombosis after 30 days and on or before 360 days	360 days
Secondary	Definite and Probable Stent Thrombosis	Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of >= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of >=70% by QCA without either angina or a positive functional study.	1800 days
Secondary	In-Segment Percent Diameter Stenosis	Relative changes that occur in the percent diameter stenosis of the segment and are provided by the following relationship: % diameter stenosis= (1-[MLD/Reference diameter]) x 100	270 days
Secondary	In-Stent and In-Segment MLD and Late Loss	In-stent and in-Segment minimal lumen diameter obtained immediately after stent implantation and at angiographic assessment at 270 days.; In-stent or in-segment late loss was defined as the difference between minimum lumen diameter (in-stent or in-segment) immediately after implantation and that obtained at angiographic follow-up at 270 days.	270 days
Secondary	Angiographic Endpoints	Angiographic subset included 115 of the 296 enrolled. Therefore, the overall number of participants analyzed for this outcome measure is 115.	270 days
Secondary	In-stent Neointimal Thickness (INT)	in-stent neointimal thickness assessed by Optical Coherence Tomography	270 days
Secondary	Percentage of Uncovered and/or Malapposed Struts	This measure assess the average proportion of uncovered and or malapposed struts measured by Optical Coherence Tomography in participants	270 days
Secondary	Lumen and Stent Area Measurements	Optical Coherence Tomography assessment of the lumen and stent area after the clinical follow up at 270 days	270 days
Secondary	Lumen and Stent Volume	Optical Coherence Tomography assessment of the lumen and stent volume after the clinical follow up at 270 days	270 days